Sr. R&D Engineer
Performs new product development activities, product evaluation and testing, process development, test fixture development and verification/validation protocol and reports.
Develop, test, and refine prototypes and new product designs. Finalize designs and creating detailed engineering specifications ensuring proper tolerancing and design for manufacturability Develop verification/validation protocols, carry out testing and write reports.
Lead portions of new product development projects or major design change projects. Manage product builds for formal testing programs Assure Design processes are in accordance with design control procedures Develop project timeline for development projects and ensure project execution. Develop and implement new processes, test fixtures and documentation methods.
Work with Regulatory/ Quality group to carry out functionally specific testing.
Work directly with Physicians/ Marketing to improve existing products and refine prototypes. Take part in design reviews and technical product reviews. Work with Directors and mangers to carry out project tasks.
Evaluate competitor products Investigate field product complaints and develop and implement improvements. Supervise technicians and/or lower level engineers.
Minimum Skills and Capabilities: Ability to organize and conduct experiments independently Ability to analyze and solve technical problems Good oral and written communication skills (English) Work well in a team environmentMinimum Knowledge & Experience required for the position:
4 year engineering degreeHands on Experience building prototypes, tooling, test fixtures Understanding of quality system requirements (e.G. 21CFR820, ISO13485). 6+ years of experience on Catheter or Endovascular device development experience